abstract
Results
Forty-two patients were entered
into trial, 31 received Vigil and 11 received standard of care.
No ≥ Grade 3 toxicity related to product was observed. A marked
induction of circulating activated T-cell population was observed
against individual, pre-processed autologous tumor in the Vigil arm as
compared to pre-Vigil baseline using IFNγ ELISPOT response (30/31
negative ELISPOT pre Vigil to 31/31 positive ELISPOT post Vigil, median
134 spots). Moreover, in correlation with ELISPOT response, RFS from
time of procurement was improved (mean 826 days/median 604 days in the
Vigil arm from mean 481 days/median 377 days in the control arm,
p = 0.033).
Conclusion
In conjunction
with the demonstrated safety, the high rate of induction of T-cell
activation and correlation with improvement in RFS justify further Phase
II/III assessment of Vigil.
0 comments :
Post a Comment
Your comments?
Note: Only a member of this blog may post a comment.